CN111514189A

CN111514189A - A pharmaceutical composition for treating sciatica and its preparation method

Info

Publication number: CN111514189A
Application number: CN202010311505.5A
Authority: CN
Inventors: 任凯杰; 任凯清; 叶茂春
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-04-20
Filing date: 2020-04-20
Publication date: 2020-08-11

Abstract

The invention discloses a medicinal composition for treating sciatica, which is prepared from the following raw materials in parts by weight: 10-30 parts of scorpion, 12-35 parts of ephedra herb, 17-29 parts of achyranthes root, 13-31 parts of myrrh, 8-29 parts of bighead atractylodes rhizome, 14-35 parts of frankincense, 20-29 parts of liquorice, 18-31 parts of stiff silkworm and 1-5 parts of nux vomica. The invention also provides a preparation method and pharmaceutical application of the composition. The traditional Chinese medicine composition provided by the invention is prepared from traditional Chinese medicines, has wide medicinal material sources, has an excellent curative effect especially on sciatica, scapulohumeral periarthritis and hyperosteogeny and neuralgia by compression, is short in treatment period, has the characteristics of wide medicinal material sources, simplicity in preparation and reliable curative effect, is prepared in a plurality of forms, and can be selected to prepare the type of the medicament according to actual production cost and use experience.

Description

A pharmaceutical composition for treating sciatica and its preparation method

Technical Field

The invention relates to the technical field of medicines, in particular to a pharmaceutical composition for treating sciatica and a preparation method thereof.

Background

The sciatic nerve is the largest and longest nerve in the human body and is easily affected by various diseases to cause pain in the sciatic nerve. Generally, sciatica is caused by a plurality of reasons, such as protrusion of intervertebral disc, lumbar hypertrophy, muscle problems and the like, which can cause sciatica in patients. At present, sciatica has been treated internationally as a disease. The most common disease causing sciatica is piriformis syndrome, which is a pain symptom caused by local edema and pressure stimulation of the sciatic nerve of a patient due to inflammation of piriformis caused by cold stimulation or fatigue. Patients with piriformis syndrome generally have hip pain accompanied by pain and numbness of thighs and shanks, and serious patients can have symptoms of dare walking of lower limbs, which are often seen in physical workers and middle-aged and elderly people. Sciatica also occurs in patients with lumbar disc herniation because the sciatic nerve is an extension of the lumbar nerve, and some patients exhibit sciatic nerve symptoms once the lumbar nerve is stimulated. The patient can cause leg pain and leg numbness while suffering from waist pain. Patients with lumbar transverse process syndrome also develop manifestations of sciatica.

At present, the treatment modes of sciatica mainly comprise traction treatment, medicine, manipulation treatment, acupuncture and surgical operations, and the traction treatment, the manipulation treatment and the acupuncture are usually long in period and difficult to cure radically; surgery is very risky and costly. In the drug treatment, the side effect of western medicines on the treatment of sciatica is more obvious, the western medicines mainly have the effect of relieving pain, and the pain relieving medicines are easy to generate drug resistance after being taken for a long time, even cause complications.

Disclosure of Invention

The invention aims to overcome the defects of the existing western medicines for treating sciatica and provides a traditional Chinese medicine composition for treating sciatica.

The invention provides a traditional Chinese medicine composition for treating sciatica, which is prepared from the following raw materials in parts by weight: 10-30 parts of scorpion, 12-35 parts of ephedra herb, 17-29 parts of achyranthes root, 13-31 parts of myrrh, 8-29 parts of bighead atractylodes rhizome, 14-35 parts of frankincense, 20-29 parts of liquorice, 18-31 parts of stiff silkworm and 1-5 parts of nux vomica.

Preferably, the pharmaceutical composition is prepared from the following raw materials in parts by weight: 12-30 parts of scorpion, 18-31 parts of ephedra herb, 21-28 parts of achyranthes root, 15-30 parts of myrrh, 14-29 parts of bighead atractylodes rhizome, 16-32 parts of frankincense, 22-29 parts of liquorice, 19-30 parts of stiff silkworm and 1-4 parts of nux vomica.

Further preferably, the pharmaceutical composition is prepared from the following raw materials in parts by weight: 25 parts of scorpion, 25 parts of ephedra herb, 25 parts of twotooth achyranthes root, 25 parts of myrrh, 25 parts of largehead atractylodes rhizome, 25 parts of frankincense, 25 parts of liquorice, 25 parts of stiff silkworm and 2 parts of nux vomica.

The preparation method of the pharmaceutical composition for treating sciatica comprises the following steps:

s1, weighing scorpion, ephedra herb, achyranthes root, myrrh, bighead atractylodes rhizome, frankincense, liquorice, stiff silkworm and nux vomica according to the weight part ratio, peeling the nux vomica, frying to brown, taking out, respectively cleaning the other medicinal materials, cutting off, drying at normal temperature, putting all the medicinal materials into a wall breaking machine together for wall breaking for 12-15min, adding a mixed solution of ethanol and water to immerse the medicinal materials, and carrying out ultrasonic treatment for 30-35 min. The mass percentage concentration of the mixture of ethanol and water is 50% of the mass of the solution of ethanol, and the mass of the mixture of ethanol and water is 5-8 times of the total mass of the medicinal materials.

S2, heating the mixture by adopting a water bath temperature of 50-65 ℃ after the ultrasonic treatment is finished, extracting the mixture for 2-2.5h in a condensing reflux mode, and collecting the extracting solution; adding mixed solution of ethanol and water into the residue, soaking the medicinal materials in water bath at 50-65 deg.C, heating, extracting for 1-1.2 hr by condensing reflux, and collecting extractive solution; adding mixed solution of ethanol and water into the residue, soaking the medicinal materials, extracting at the same water bath temperature for 1-1.2 hr by condensing and refluxing; the 3 times of extracts were combined. The mixture of ethanol and water is a solution with the ethanol concentration of 50 percent by mass.

S3, preparing medicinal powder: mixing the extractive solutions, filtering with 10 μm filter membrane, concentrating the filtrate under reduced pressure at-0.09 Mpa and 55 deg.C to obtain soft extract with relative density of 1.30 at 60 deg.C, and drying under reduced pressure at-0.09 Mpa and 55 deg.C to obtain medicinal powder.

The powder obtained in step S3 may be further processed into tablets by the following steps:

s4, sieving the medicinal powder obtained in the step S3 by a 100-mesh pharmacopeia sieve;

s5, adding maltooligosaccharide accounting for 10% of the total mass of the medicinal powder, sodium carboxymethyl starch accounting for 1.5% of the total mass of the medicinal powder and dextrin accounting for 10% of the total mass of the medicinal powder into the sieved medicinal powder, uniformly mixing, and then adding ethanol solution with the mass percentage concentration of 85-95% to granulate;

s6, drying at 65 ℃ after granulation is finished to enable the moisture content to be less than 5%, and then grading by adopting a 20-mesh sieve;

s7, adding magnesium stearate accounting for 0.5 percent of the total mass of the medicinal powder after finishing the granulation, uniformly mixing, tabletting, and packaging with a plastic sealing plate.

Or further preparing the medicinal powder prepared in the step S3 into powder or capsules, wherein the steps are as follows:

pulverizing the medicinal powder obtained in step S3, sieving with 16-20 mesh sieve, grading, and packaging into 10g medicinal bag or capsule shell.

Compared with the prior art, the invention has the advantages that:

(1) the traditional Chinese medicine composition adopts pure traditional Chinese medicines in proportion, has the effects of calming endogenous wind, relieving spasm, dredging collaterals, relieving pain, promoting blood circulation, removing blood stasis and applying medicine according to symptoms, has short treatment period and particularly has excellent curative effect on sciatica, scapulohumeral periarthritis and hyperosteogeny and neuralgia by pressing, and specially aims at nerve pain caused by neuroinflammation, rheumatic arthralgia and meridian obstruction.

(2) The scorpion has the efficacies of calming endogenous wind, relieving spasm, dredging collaterals, relieving pain, attacking toxin and resolving masses, has excellent curative effect on headache, lumbago and leg pain caused by wind-cold-dampness arthralgia, has the antithrombotic and antibacterial effects, and has the antibacterial and collateral-dredging effects on sciatica caused by bacterial infection. Herba Ephedrae has effects of regulating blood pressure, relieving inflammation, resisting bacteria and virus, exciting central nerve, tonifying heart, and promoting urination. Achyranthis radix has effects of removing blood stasis, dredging channels, strengthening tendons and bones, drawing blood, resisting inflammation, and relieving pain. Myrrha has effects of promoting blood circulation, relieving pain, eliminating swelling, and promoting granulation. Atractylodis rhizoma can improve immunity of patients. The frankincense has the effects of diminishing inflammation, relieving pain, stimulating the menstrual flow, preventing corrosion, reducing swelling and promoting tissue regeneration, and has a certain repairing effect on nerve injury. Licorice root, radix Glycyrrhizae can clear away heat and toxic materials and relieve neuropathic pain. Bombyx Batryticatus has effects of calming endogenous wind, relieving spasm, dispelling pathogenic wind, relieving pain, dredging collaterals, and protecting channels. The nux vomica has the effects of resolving masses, reducing swelling, dredging collaterals and relieving pain, and has better treatment effect on traumatic injury, rheumatism, obstinate arthralgia and numbness and paralysis. Strychnos nux-vomica can excite nerve, clear heat and remove toxicity.

(3) Compared with other medicaments, the Chinese medicinal composition has the characteristics of wide medicinal material source, simple preparation and reliable curative effect, and has better curative effect on various neuroinflammations and rheumatism pain.

Additional advantages, objects, and features of the invention will be set forth in part in the description which follows and in part will become apparent to those having ordinary skill in the art upon examination of the following or may be learned from practice of the invention.

Detailed Description

The following description of the preferred embodiments of the present invention is provided for the purpose of illustration and description, and is in no way intended to limit the invention.

Example 1

A preparation method of a traditional Chinese medicine composition for treating sciatica comprises the following steps:

s1, weighing the following raw materials in parts by weight: 10 parts of scorpion, 12 parts of ephedra herb, 29 parts of twotooth achyranthes root, 31 parts of myrrh, 8 parts of largehead atractylodes rhizome, 14 parts of frankincense, 29 parts of liquorice, 31 parts of stiff silkworm and 1 part of nux vomica. Peeling semen Strychni, parching to brown, taking out, cleaning the rest materials, cutting, air drying at room temperature, breaking cell wall in cell wall breaking machine for 15min, adding ethanol and water mixed solution as extraction solvent, soaking the materials, and performing ultrasonic treatment for 30-35 min. The mass percentage concentration of the mixture of ethanol and water is 50% of the mass of the solution of ethanol, and the mass of the mixture of ethanol and water is 5-8 times of the total mass of the medicinal materials.

S2, heating at 50 ℃ in a water bath after the ultrasonic treatment, extracting for 2.5h in a condensing reflux mode, filtering, and collecting an extracting solution; adding mixed solution of ethanol and water into the residue after filtration to immerse the medicinal materials, heating in water bath at 50 deg.C, extracting for 1-1.2 hr by condensing reflux, filtering, and collecting the extractive solution; adding mixed solution of ethanol and water into the residue after filtration to immerse the medicinal materials, heating in water bath, and extracting for 1-1.2 hr by condensing reflux; the 3 times of extracts were combined. The mixture of ethanol and water is a solution with the ethanol concentration of 50 percent by mass.

Example 2

s1, weighing the following raw materials in parts by weight: 30 parts of scorpion, 35 parts of ephedra herb, 17 parts of twotooth achyranthes root, 13 parts of myrrh, 29 parts of largehead atractylodes rhizome, 35 parts of frankincense, 20 parts of liquorice, 18 parts of stiff silkworm and 5 parts of nux vomica. Peeling semen Strychni, parching to brown, taking out, cleaning the rest materials, cutting, air drying at room temperature, breaking cell wall in cell wall breaking machine for 12min, adding ethanol and water mixed solution as extraction solvent, soaking the materials, and performing ultrasonic treatment for 30-35 min. The mass percentage concentration of the mixture of ethanol and water is 50% of the mass of the solution of ethanol, and the mass of the mixture of ethanol and water is 8 times of the total mass of the medicinal materials.

S2, heating at 65 ℃ in a water bath after the ultrasonic treatment, extracting for 2.5h in a condensing reflux mode, filtering, and collecting an extracting solution; adding mixed solution of ethanol and water into the residue after filtration to immerse the medicinal materials, heating in water bath at 65 deg.C, extracting for 1-1.2 hr by condensing reflux, filtering, and collecting the extractive solution; adding mixed solution of ethanol and water into the residue after filtration to immerse the medicinal materials, heating in water bath, and extracting for 1-1.2 hr by condensing reflux; the 3 times of extracts were combined. The mixture of ethanol and water is a solution with the ethanol concentration of 50 percent by mass.

s5, adding maltooligosaccharide accounting for 10% of the total mass of the medicinal powder, sodium carboxymethyl starch accounting for 1.5% of the total mass of the medicinal powder and dextrin accounting for 10% of the total mass of the medicinal powder into the sieved medicinal powder, uniformly mixing, and adding ethanol solution with the mass percentage concentration of 85-95% to perform granulation.

S6, drying at 65 ℃ after granulation is finished to enable the moisture content to be less than 5%, and then carrying out granulation by adopting a 20-mesh sieve.

Example 3

s1, weighing the following raw materials in parts by weight: 12 parts of scorpion, 18 parts of ephedra herb, 21 parts of achyranthes root, 15 parts of myrrh, 14 parts of largehead atractylodes rhizome, 32 parts of frankincense, 24 parts of liquorice, 18 parts of stiff silkworm and 3 parts of nux vomica. Peeling semen Strychni, parching to brown, taking out, cleaning the rest materials, cutting, air drying at room temperature, breaking cell wall in cell wall breaking machine for 15min, adding ethanol and water mixed solution as extraction solvent, soaking the materials, and performing ultrasonic treatment for 30-35 min. The mass percentage concentration of the mixture of ethanol and water is 50% of that of the ethanol, and the mass of the mixture of ethanol and water is 6 times of the total mass of the medicinal materials.

S4, preparation: and (4) crushing the medicinal powder obtained in the step (S3), mechanically homogenizing, sieving with a 16-20-mesh sieve, grading, and subpackaging with a medicinal bag with the specification of 1g or filling into a capsule shell to prepare capsules.

Example 4

s1, weighing the following raw materials in parts by weight: 25 parts of scorpion, 25 parts of ephedra herb, 25 parts of twotooth achyranthes root, 25 parts of myrrh, 25 parts of largehead atractylodes rhizome, 25 parts of frankincense, 25 parts of liquorice, 25 parts of stiff silkworm and 2 parts of nux vomica. Peeling semen Strychni, parching to brown, taking out, cleaning the rest materials, cutting, air drying at room temperature, breaking cell wall in cell wall breaking machine for 15min, adding ethanol and water mixed solution as extraction solvent, soaking the materials, and performing ultrasonic treatment for 30-35 min. The mass percentage concentration of the mixture of ethanol and water is 50% of the mass of the solution of ethanol, and the mass of the mixture of ethanol and water is 8 times of the total mass of the medicinal materials.

The application of the pharmaceutical composition or the pharmaceutical preparation in preparing the medicine for treating sciatica. The usage and dosage are as follows:

the powder is administered at a dose of 1g each time, and is administered once a day after lunch and dinner for adults.

The tablet is about 0.5g, and is taken by adult once after lunch and dinner every day, 2 tablets each time.

The capsule is about 0.5g, and is administered once after lunch and dinner for adult respectively, 2 capsules each time.

Notes and contraindications: (1) it is forbidden for patients allergic to the medicine. (2) Greasy, seafood, mutton, dog meat, fishy smell, alcoholism and spicy food are avoided when the medicine is taken, and the medicine is avoided for pregnant women and infants.

The beneficial effects of the medicament of the present invention are further illustrated by clinical tests, which are conducted by using capsules prepared from the Chinese medicinal composition prepared in the above example 4 of the present invention.

1. Clinical data

(1) The test method comprises the following steps: is used clinically.

(2) Test unit: the Qingyun Zhenzhuang outpatient room in Linyi city.

(3) Test subjects:

1) the source of the cases is: and 60 sciatica patients in 3 and 11 days in 2019-10 and 13 days in 2019.

2) Case inclusion criteria: the clinical diagnosis standard of sciatica is met, and the auxiliary diagnosis such as lumbar and hip pain, lumbar disc herniation and compression, sciatic neuritis, sedentary pain, lumbar and pelvic X-ray films, lumbar puncture, magnetic resonance examination, lumbar CT, spinal angiography and the like is confirmed when the patient bends over the waist or moves the lower limbs.

3) The specific symptoms are as follows: pain in the waist, hips, legs and even feet, and increased pain from coughing, bending or moving the lower extremities.

4) Traditional Chinese medicine syndrome differentiation: cold-dampness congealing collaterals, dampness-heat invading collaterals, blood stasis obstructing collaterals, liver and kidney deficiency; and (3) Western diagnosis: radiation pain, X-ray examination: the lumbosacral vertebra X-ray plain film can find out the indirect symptoms of intervertebral disc protrusion such as scoliosis and intervertebral space narrowing, or degenerative change of spine, sacroiliac arthritis, congenital abnormality, spinal tuberculosis, metastatic tumor damage vertebral body or lumbar vertebra fracture, etc. The spinal canal radiography can make clear diagnosis. CT or nuclear magnetic resonance examination can be used for determining pathological changes such as intervertebral disc protrusion, intraspinal tumor, spinal stenosis and the like.

(4) The implementation scheme is as follows: patients included were randomized into treatment groups comprising 15 males and 15 females and a control group; age 25-65 years, mean age (43 ± 4.5) years; the course of the disease is 12-14 months, and the average course of the disease (12.8 +/-0.31) months. The control group contained 15 males and 15 females; age 25-65 years, mean age (43 ± 4.5) years; the course of the disease is 12-14 months, and the average course of the disease (12.8 +/-0.47) months. The comparison of the two groups of patients in terms of age, sex, clinical symptoms and disease course shows that P is more than 0.05, and the difference has no statistical significance and is comparable.

(5) The diagnosis method comprises the following steps: the medical history of the patient mainly includes pain in the waist, hip, legs and even feet, whether the pain is aggravated by cough, bending or moving lower limbs, the pain and duration are important, and whether the effective communication is accompanied by other symptoms, the past history and the like.

(6) The treatment method comprises the following steps:

the treatment group is based on the syndrome differentiation of the traditional Chinese medicine, and the patients take the medicine of the invention once after lunch and dinner every day, and each time takes 2 capsules, each capsule is about 0.5 g.

The control group uses fenbidon once for 1 granule, 2 times a day; vitamin B1 is administered 1 granule at a time, 1 time a day.

(7) The treatment results are as follows:

after 15 male patients and 15 female patients in the treatment group are treated by the medicament for 2-5 days, the symptoms are basically eliminated, and the total effective rate is 99%. After 15 male patients and 15 female patients in the control group are treated by oral amoxicillin capsules and omeprazole for 3-5 days, the symptoms of 28 patients are eliminated, and 1 male patient and 1 female patient have slight symptoms, and the total effective rate is 93%.

(8) And (4) conclusion: the grouping treatment of 60 patients shows that the medicament has good curative effect on sciatica, can obviously relieve the symptoms of the patients, and has short treatment period and no obvious side effect in terms of comprehensive curative effect.

Typical case 1

If a patient is a male in the age of 45 years and the disease course is 14 months, the patient is engaged in the construction industry, the disease condition is long, the right lower limb is often painful and numb, and the activity is limited. Patients complain that the work site is dry before one month, the pain of the right lower limb is suddenly felt, the disease condition is improved after taking fenbizido, and the right lower limb still feels pain. The medicine is used twice a day, 2 pills are taken each time, symptoms disappear after 4 days of treatment, pain does not occur in a construction site, limb pain sensation, touch sensation and position sensation are normal after repeated diagnosis, physiological reflex exists normally, no pain and rebound pain exist, pathological reflex is not led out, and rehabilitation can be determined.

Typical case 2

The patient is Lian-Shi, female, 46 years old, farmer, 12 months old, mostly live in farming everyday, often stoop, and the disease is related to long-term strain, qi stagnation and blood stasis. After examination, the patient feels pain in the left lower limb and hip, does not dare to turn over when sleeping at night, and has dysfunction in the movement and sensation of the left lower limb, and the patient is identified as piriformis syndrome, namely sciatica. The medicine is prescribed to be taken twice a day, 2 pills are taken each time, symptoms disappear after 5 days of treatment, physiological reflex is rechecked to normally exist, no pressure pain and rebound pain exist, pathological reflex is not led out, and the rehabilitation can be determined.

The treatment effects show that the medicament has stable curative effect and quick response when used for treating sciatica, has good treatment effect compared with western medicines, and does not cause adverse reaction in the treatment process. The medicine can be prepared into various forms of medicaments, and the type of the prepared medicament can be selected according to the actual production cost and the use experience. In addition, the traditional Chinese medicine composition has a good curative effect on sciatica and also has a good curative effect on other neuroinflammation and pressure pain.

Although the present invention has been described with reference to a preferred embodiment, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. The pharmaceutical composition for treating sciatica is characterized by being prepared from the following raw materials in parts by weight: 10-30 parts of scorpion, 12-35 parts of ephedra herb, 17-29 parts of achyranthes root, 13-31 parts of myrrh, 8-29 parts of bighead atractylodes rhizome, 14-35 parts of frankincense, 20-29 parts of liquorice, 18-31 parts of stiff silkworm and 1-5 parts of nux vomica.

2. The pharmaceutical composition for treating sciatica according to claim 1, characterized by being prepared from the following raw materials in parts by weight: 12-30 parts of scorpion, 18-31 parts of ephedra herb, 21-28 parts of achyranthes root, 15-30 parts of myrrh, 14-29 parts of bighead atractylodes rhizome, 16-32 parts of frankincense, 22-29 parts of liquorice, 19-30 parts of stiff silkworm and 1-4 parts of nux vomica.

3. The pharmaceutical composition for treating sciatica according to claim 2, wherein the pharmaceutical composition is prepared from the following raw materials in parts by weight: 25 parts of scorpion, 25 parts of ephedra herb, 25 parts of twotooth achyranthes root, 25 parts of myrrh, 25 parts of largehead atractylodes rhizome, 25 parts of frankincense, 25 parts of liquorice, 25 parts of stiff silkworm and 2 parts of nux vomica.

4. A process for the preparation of a pharmaceutical composition according to any one of claims 1 to 3 for the treatment of sciatica comprising the following steps:

s1, weighing scorpion, ephedra herb, achyranthes root, myrrh, bighead atractylodes rhizome, frankincense, liquorice, stiff silkworm and nux vomica according to the weight part ratio, peeling the nux vomica, frying to brown, taking out, respectively cleaning the rest medicinal materials, cutting off, drying at normal temperature, putting all the medicinal materials into a wall breaking machine together for wall breaking for 12-15min, adding a mixed solution of ethanol and water to immerse the medicinal materials, and carrying out ultrasonic treatment for 30-35 min;

s2, heating the mixture by adopting a water bath temperature of 50-65 ℃ after the ultrasonic treatment is finished, extracting the mixture for 2-2.5h in a condensing reflux mode, and collecting the extracting solution; adding mixed solution of ethanol and water into the residue, soaking the medicinal materials in water bath at 50-65 deg.C, heating, extracting for 1-1.2 hr by condensing reflux, and collecting extractive solution; adding mixed solution of ethanol and water into the residue, soaking the medicinal materials, extracting at the same water bath temperature for 1-1.2 hr by condensing and refluxing; mixing the extractive solutions for 3 times;

5. The method for preparing a pharmaceutical composition for the treatment of sciatica as set forth in claim 4, further comprising steps S4, S5, S6, S7, specifically as follows:

6. The method of preparing a pharmaceutical composition for the treatment of sciatica as set forth in claim 4, further comprising step S4: pulverizing the medicinal powder obtained in step S3, sieving with 16-20 mesh sieve, grading, and packaging into 10g medicinal bag or capsule shell.

7. The method of preparing a pharmaceutical composition for the treatment of sciatica as set forth in any one of claims 4 to 6, wherein the mixture of ethanol and water used in steps S1 and S2 is a 50% ethanol solution by weight.

8. The method of claim 7, wherein in step S1, the amount of the mixture of ethanol and water is 5-8 times the total weight of the herbs.